MONDAY, SEPTEMBER 26, 2016

GSK announces phase III global program to evaluate malaria treatment

GlaxoSmithKline and the Medicines for Malaria Venture began a phase III global program this week to evaluate the efficacy and safety of an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria.

"P. vivax malaria can affect people of all ages and is particularly insidious because it has the potential to remain dormant within the body in excess of a year, and causes some patients to experience repeated episodes of illness after the first mosquito bite," Nicholas Cammack, the head of Tres Cantos Medicines Development Center for Diseases of the Developing World, said. "Our investigation of tafenoquine for the treatment of P. vivax malaria is part of GSK's efforts to tackle the global burden of malaria. Working with our partners, including MMV, we are determined to stop malaria in all its forms."

The phase III program for tafenoquine includes two randomized, double-blind treatment studies to investigate adult patients with P. vivax malaria. The "DETECTIVE" study seeks to evaluate the efficacy, safety and tolerability of tafenoquine as a radical P. vivax cure when co-administered with the blood stage anti-malarial treatment chlorine.

The "GATHER" study will assess the incidence of hemolysis and the safety and efficacy of tafenoquine compared to primaquine, the only approved treatment available for the radical cure of P. vivax malaria.

"One of the big challenges we face in tackling malaria is to have new medicines to prevent relapse, caused by dormant forms of P. vivax," Dr. Timothy Wells, MMV's chief scientific officer, said. "The phase III program is designed to build upon the promising results of the phase IIb study which showed that treatment with tafenoquine prevented relapses. If successful, tafenoquine has the potential to become a major contributor to malaria elimination. It's a great privilege to be working with GSK on this project; they have a clear commitment to changing the face of public health in the countries in which we are working."